ReCerf® Hip Resurfacing Arthroplasty

Product Brochure

Dynamic Evolution

®

2 | ReCerf® Hip Resurfacing Arthroplasty | Product Brochure

Contents 1 Introduction 3

2 Product Description 4

3 Main Features 5

4 Product Introduction 6

5 Product Range 7

Manufactured by MatOOrtho Limited

19/20 Mole Business Park | Randalls Road | Leatherhead | Surrey | KT22 7BA | UK

T: +44 (0)1372 224 200 | info@MatOOrtho.com

For more information visit: www.MatOOrtho.com

© MatOOrtho Limited 2019

All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording or any information storage and retrieval system.

ReCerf® Hip Resurfacing Arthroplasty | Product Brochure | 3

1 Introduction Why Hip Resurfacing? Hip resurfacing offers patients with hip arthritis a more conservative treatment option, prolonging the time before a total hip replacement may be required and the entire femoral head is removed.

Clinical experience has shown that successful hip resurfacing enables patients to return to a variety of work, sport and leisure activities without restriction as compared to total hip replacement (THR)1,2.

Modern-day hip resurfacing was introduced in 1997 and with its appeal saw a dramatic rise in use over its first decade (1997-2007). Despite the advantages and success in many patients, reports of failures that highlighted the criticality of patient selection, surgical technique and implant positioning3,4 led to a decline in the following decade (2007-2017). Problems were exacerbated by critical deficiencies of badly designed prostheses5 and many reports over-generalised the issues and related them to the use of metal. These issues are now better-understood and the poorly performing devices have been withdrawn. Recent reports show that with well-designed cobalt-chrome hip resurfacing devices, relatively younger patients not only remain more active1,2 they may also be less likely to require revision surgery within 20 years when compared to those that receive a THR2,6.

Further information on the clinical experience of hip resurfacing can be found in the ADEPT® Hip Resurfacing Clinical Rationale7 and the ReCerf® Hip Resurfacing Arthroplasty Clinical Rationale8.

Introducing ReCerf® Hip Resurfacing Arthroplasty In a new technological advancement, the ‘all-ceramic’ ReCerf® Hip Resurfacing Arthroplasty provides an alternative to metal hip resurfacing devices that addresses both known and perceived risk of complications resulting from adverse reaction to metal, including patients with hypersensitivity to metal.

ReCerf® Hip Resurfacing Arthroplasty features the key design characteristics of the successful ADEPT® Hip Resurfacing System and is provided by the original manufacturer of the successful and still-used metal hip resurfacing devices, the ADEPT® and the Birmingham Hip Replacement (BHR).

4 | ReCerf® Hip Resurfacing Arthroplasty | Product Brochure

2 Product Description ReCerf® Hip Resurfacing is made up of just two components, both made from the advanced toughened BIOLOX® delta ceramic material (CeramTec GmbH)9. The surgery requires no additional ‘stem’, ‘neck-sleeve’, ‘liner’, ‘shell’ or screws and there are no metal or polyethylene components.

The bearing interface is ceramic-on-ceramic, a proven material used in hip replacements for over 15 years with the lowest wear characteristics of all available articulations9, and with optimum clearance for each size. Resurfacing Head

The ReCerf® femoral head component is an all-ceramic thin shell that replaces the worn cartilage of the patient’s femoral head. The component is provided in a range of 13 sizes, sufficient to cater for the whole adult population. Each size increment differs by 2mm in diameter (i.e. 1mm increments at the bearing surface) to better retain the patient’s natural femoral head diameter and restore normal joint mechanics.

The bearing surface of the femoral component is highly polished with optimised edge radii to maximise bearing surface area without compromising tissue.

The implant geometry is the same as the proven ADEPT® Hip Resurfacing and requires the same instrumentation to size, align and prepare the femoral head that the surgeon is already experienced in using with the ADEPT® Hip Resurfacing.

The component is cemented to the femoral head and includes internal features to enhance fixation. A short proportionally-sized stem inside the head centralises and guides the implant into place.

Acetabular Cup

The ReCerf® acetabular cup is an all-ceramic monoblock component with a thin wall requiring minimal removal of acetabular bone to maintain the patient’s natural hip bearing diameter. The nominal wall thickness is within the range of normal healthy acetabular cartilage thickness.

The acetabular cup is provided in 13 sizes, sufficient to cater for the whole adult population, and each size increases by 2mm in diameter to match its compatible femoral head component.

The bearing surface of the acetabular component is highly polished to maximise surface area without compromising tissue. The internal geometry and edge radii are optimised for maximum range of motion without contact between the edge of the cup and the femoral neck, combined with maximum ‘coverage’ to keep the load-bearing articulating surface area within the bearing.

Secure press-fit fixation is achieved using DeltaFIX® coating technology – a thin, rough-surface, plasma-sprayed titanium overlaid with hydroxyapatite (HA) coating – to create a bone-interface widely used in cementless fixation of implants. The external geometry is a full hemisphere to maximise the fixation interface.

Accurate sizing, positioning and fit is achieved with the same precise instrumentation that the surgeon is already experienced in using with the ADEPT® Hip Resurfacing.

ReCerf® Hip Resurfacing Arthroplasty | Product Brochure | 5

3 Main Features Hip resurfacing may offer a number of benefits over total hip replacement, including:

Preservation of the femur, Resistance to dislocation, A return to normal function, sport and manual work, Maintains the option of a standard THR in later life.

Resurfacing For All Patients ReCerf® provides an early intervention option for patients with standard primary indications. The all-ceramic construction means that it can be used for patients with particular concerns for the alternative metal hip resurfacing devices. Intended for relatively younger or more active patients who are otherwise likely to require further surgery in their lifetime, ReCerf® may enable patients to return to normal active lifestyle and work. ReCerf® is provided in a wide range of sizes to serve the whole adult population.

Premium Material Choice ReCerf® is manufactured from toughened, fracture-resistant BIOLOX® delta ceramic (CeramTec GmbH). BIOLOX® delta has been used in up to 3 million joint replacements worldwide since 2003 and is associated with excellent long-term clinical results9. It is well-proven with excellent functional outcomes in large diameter ceramic-on-ceramic hips9. It is the most biologically inert material with no known side effects or long term adverse reactions and the optimised low friction and lubrication bearing has the lowest wear characteristics of all articulations9. Being all-ceramic, ReCerf® has no corrosive material couplings seen in most alternative joint replacement devices.

Optimised Design The component wall thicknesses are optimised to minimise bone removal without compromising strength, which makes ReCerf® a truly bone conserving design replacing little more than the worn cartilage. The minimally offset centre and contained arc enables a full range-of-motion combined with consistent cup coverage to maintain a load-bearing area safely within the confines of the bearing. The bearing size increments increase in 1mm radial steps (2mm diameter components) to replicate the patient’s natural bearing diameter and the internal stem design is proportionally sized for optimum load transfer to the patient’s femoral head.

6 | ReCerf® Hip Resurfacing Arthroplasty | Product Brochure

Simple and Proven Instrumentation ReCerf® uses the same well-proven surgical technique and instrumentation used by hip resurfacing surgeons for the ADEPT® Hip Resurfacing System. Features of the instrumentation include optimised sizing and bone preparation instruments, simple, reliable cup and head positioning and alignment, and a full visibility, low profile cup introduction system. ReCerf® is supported by an international surgeon training programme.

Focused on Clinical Outcomes The ReCerf® Hip Resurfacing Arthroplasty was developed at the ‘Home of Resurfacing’ by the team that developed and manufactured successful modern-day hip resurfacing (BHR and ADEPT®) and with input from surgeons world-renowned for their experience and expertise in hip resurfacing surgery. ReCerf® retains the key design features of hard-bearing hip replacement devices with over 50 years of clinical success. ReCerf® is being introduced to the market with an international multicentre study.

4 Product Introduction ReCerf® Hip Resurfacing is being made available to experienced hip resurfacing surgeons who are approved by their competent health authority, have received full training from an existing user of the device, and according to the Instructions for Use10 (IFU) supplied with the product. The surgeon is ultimately responsible for selecting the appropriateness of the ReCerf® device for individual patients based on the IFU and their experience.

References 1 Hellman MD, Ford MC, Barrack RL. Is there evidence to support an indication for surface replacement arthroplasty? A

systematic review. Bone Joint J. 2019; 101-B (1 supple A): 32-40. 2 Jonas SC, Whitehouse MR, Bick S, Bannister GC, Baker RP. An 18-year comparison of hybrid total hip replacement and

Birmingham hip resurfacing in active young patients. Hip Intl. 2019 [Epub]: https://doi.org/10.1177/1120700018814710. 3 Van Der Straeten C, De Smet KA. Current expert views on metal-on-metal hip resurfacing arthroplasty. Consensus of

the 6th advanced Hip resurfacing course, Ghent, Belgium, May 2014. Hip Intl. 2016; 26 (1):1-7. 4 National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. 15th Annual Report, 2018: Surgical data

to 31 December 2017. www.njrreports.org.uk. 5 Langton DJ, Jameson SS, Joyce TJ, Gandhi JN, Sidaginamale R, Mereddy P, Lord J, Nargol AV. Accelerating failure rate

of the ASR total hip replacement. J Bone Joint Surg Br. 2011; 93 (8): 1011-6. 6 Australian Orthopaedic Association National Joint Replacement Registry. Hip, Knee & Shoulder Arthroplasty: 2018

Annual Report. Adelaide: AOA. 2018. https://aoanjrr.sahmri.com. 7 MatOrtho Limited. ADEPT® Hip Resurfacing System: Clinical Rationale. 2019; ML-300-048: www.matortho.com. 8 MatOrtho Limited. ReCerf® Hip Resurfacing Arthroplasty: Clinical Rationale. 2019; ML-300-048: www.matortho.com. 9 https://www.ceramtec.com/files/mt_biolox_ceramic_on_ceramic_en.pdf. 10 MatOrtho Limited. ReCerf® Instructions for Use. 2018; ML-400-498.

ReCerf® Hip Resurfacing Arthroplasty | Product Brochure | 7

5 Product Range Size range ReCerf® Hip Resurfacing is provided in a comprehensive size range to suit the whole adult population. Each size increases by 1mm at the bearing surface (2mm diameter) and every femoral head component is paired with a colour-code matching acetabular cup.

The optimum size for each individual patient is estimated from preoperative x-rays or CT data and confirmed during the surgical procedure.

Product Codes Femoral Head 104-040 ReCerf® Ceramic Resurfacing Head 40mm104-042 ReCerf® Ceramic Resurfacing Head 42mm104-044 ReCerf® Ceramic Resurfacing Head 44mm

104-046 ReCerf® Ceramic Resurfacing Head 46mm104-048 ReCerf® Ceramic Resurfacing Head 48mm104-050 ReCerf® Ceramic Resurfacing Head 50mm

104-052 ReCerf® Ceramic Resurfacing Head 52mm

104-054 ReCerf® Ceramic Resurfacing Head 54mm104-056 ReCerf® Ceramic Resurfacing Head 56mm 104-058 ReCerf® Ceramic Resurfacing Head 58mm

104-060 ReCerf® Ceramic Resurfacing Head 60mm 104-062 ReCerf® Ceramic Resurfacing Head 62mm

104-064 ReCerf® Ceramic Resurfacing Head 64mm

Acetabular Cup 104-401 ReCerf® Ceramic Resurfacing Cup 40/46 mm

104-421 ReCerf® Ceramic Resurfacing Cup 42/48 mm

104-441 ReCerf® Ceramic Resurfacing Cup 44/50 mm 104-461 ReCerf® Ceramic Resurfacing Cup 46/52 mm

104-481 ReCerf® Ceramic Resurfacing Cup 48/54 mm

104-501 ReCerf® Ceramic Resurfacing Cup 50/56 mm 104-521 ReCerf® Ceramic Resurfacing Cup 52/58 mm

104-541 ReCerf® Ceramic Resurfacing Cup 54/60 mm 104-561 ReCerf® Ceramic Resurfacing Cup 56/62 mm 104-581 ReCerf® Ceramic Resurfacing Cup 58/64 mm 104-601 ReCerf® Ceramic Resurfacing Cup 60/66 mm 104-621 ReCerf® Ceramic Resurfacing Cup 62/68 mm 104-641 ReCerf® Ceramic Resurfacing Cup 64/70 mm

Note: Standard Supply includes Resurfacing Head Sizes 40-58mm and Cup Sizes 40/46-58/64mm; Head Sizes 60-64mm and Cup Sizes 60/66-64/70mm are available on request.

ReCerf® Hip Resurfacing Arthroplasty | Product Brochure | 8

MatOOrtho Limited | 19/20 Mole Business Park | Randalls Road | Leatherhead | Surrey | KT22 7BA | UK

T: +44 (0)1372 224 200 | info@MatOOrtho.com | For more information visit: www.MatOOrtho.com Part No. ML-300-176 | Issue 5